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A proof of concept (POC) study will be conducted in 44 volunteers that have been fully vaccinated against hepatitis B in the past (at least 5 years ago) to assess the safety and immunogenicity of intradermal vaccination with hepatitis B surface vaccine antigen using a newly developed intradermal injection device VAX-ID, compared to intramuscular and intradermal (Mantoux technique) injection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intramuscular group | Active Comparator | These subjects will receive one intramuscular injection of 1.0cc HBVAXPRO 10mcgr/ml (Sanofi Pasteur-MSD) with syringe and needle in the deltoid region. |
|
| Intradermal group (Mantoux) | Experimental | These subjects will receive one intradermal injection with mantoux technique in the forearm. 0.1cc of HBVAXPRO 40mcgr/ml (Sanofi Pasteur-MSD) will be injected. |
|
| Intradermal group (VAX-ID) A | Experimental | These subjects will receive one intradermal injection with the newly developed intradermal injection device VAX-ID in the forearm. 0.1cc of HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD) will be injected. |
|
| Intradermal group (VAX-ID) B | Experimental | These subjects will receive two intradermal injections with two newly developed intradermal injection devices VAX-ID in both forearms each 0.1cc of HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD) will be injected. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VAX-ID | Device | 0.1cc HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD) with each injection |
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| Measure | Description | Time Frame |
|---|---|---|
| Anamnestic response after intradermal or intramuscular hepatitis B booster vaccination in previously fully immunized subjects | after 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: solicited local and systemic reactions, unsolicited adverse events and Serious Adverse Events occurrence, intensity and relationship to vaccination of all Adverse Events reported during the 14-day follow-up period after the challenge dose | during 14 days post vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pierre Van Damme, Prof | Centre for the Evaluation of Vaccination Vaccine & Infectious Disease Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for the Evaluation of Vaccination Vaccine & Infectious Disease Institute | Wilrijk | Antwerp | 2610 | Belgium |
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| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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| ID | Term |
|---|---|
| D007271 | Injections, Intradermal |
| D007273 | Injections, Intramuscular |
| ID | Term |
|---|---|
| D007279 | Injections, Subcutaneous |
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
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| 1.0 cc HBVAXPRO 10mcgr/ml (Sanofi Pasteur MSD) | Drug | 1.0 cc HBVAXPRO 10mcgr/ml (Sanofi Pasteur MSD) |
|
|
| 0.1cc HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD) | Drug | 0.1cc HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD) with each injection |
|
|
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D013812 |
| Therapeutics |